510(k) K063239 ยท FPK Tubing, Fluid Delivery
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Dec 11, 2006 |
| Received | Oct 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced injection sites and OPTION-LOK MICRODRIP SOLUSET, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake F Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with capped port and CLAVE filter SOLUSET, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lak Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77.5 inch with 2 pre-pierced injection sites and OPTION-LOK, SOLUSET, MICRODRIP with, 60 drops/mL, a sterile Rx single use device, Hospira Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with 2 CLAVE ports SOLUSET, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL US Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, CVP Manometer, latex-free, Y-type primary IV set, nonvented, 86.5 inch with pre-pierced injection site, and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Fores Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch, piggyback with drop-in blunt cannula and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with OPTION-LOK, non-DEHP, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa R Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.